Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)

Last updated: December 2, 2025
Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Muscle Pain

Reflex Sympathetic Dystrophy Syndrome (Rsds)

Treatment

I-One

Clinical Study ID

NCT05922618
PeCFoA
  • Ages > 18
  • All Genders

Study Summary

The investigators hypothesize that the association of I-ONE® therapy with standard rehabilitation treatment can optimize the clinical and functional recovery of patients with pulsed electromagnetic fields (PEMFs) (I-ONE® therapy) of the foot or ankle.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of type I CRPS according to the Budapest criteria (table 1)

  • Type I CRPS involving the ankle or foot

  • Onset of CRPS type I up to a maximum of 3 years after the symptomatic event

  • Pain on visual analog scale (VAS) scale quantified as intensity at least ≥ 5 atrecruitment

  • Pharmacological treatment with first infusion cycle of neridronate

Exclusion

Exclusion Criteria:

  • Neurological pathologies (stroke, degenerative, traumatic pathologies)

  • Local neurological impairment (type II CRPS), confirmed by a conduction test orsimilar

  • Cardiac pacemaker, treatment site malignancy

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: I-One
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
December 01, 2025

Study Description

Study design; spontaneous, prospective, randomized study with control group.

Purpose of the study:

evaluate the functional clinical improvement of the foot/ankle joint with algodystrophic pathology following a standard rehabilitation treatment and home biophysical treatment and local biophysical stimulation with I-ONE® therapy (IGEA SpA).

Connect with a study center

  • Angela Notarnicola

    Bari, 70124
    Italy

    Site Not Available

  • Angela Notarnicola

    Bari 3182351, 70124
    Italy

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.